Escitalopram for Anxiety

(PrEcISE Trial)

Overseen By Heidi K Schroeder, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Cincinnati

Must not be taking: SSRIs, Psychiatric medications

Disqualifiers: Mood disorders, Intellectual disability, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

132 Participants Needed

Trial Summary

What is the purpose of this trial?

This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.

Will I have to stop taking my current medications?

The trial requires that participants have not been treated with SSRIs (a type of antidepressant) within 12 weeks of starting the study and not be on any medication with psychiatric effects that need more than 5 half-lives to clear from the body. If you're on such medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug escitalopram for anxiety?

Research shows that escitalopram is effective in treating various anxiety disorders, including generalized anxiety disorder, social anxiety disorder, and panic disorder. It is well-tolerated and often works faster than similar drugs like citalopram, making it a good option for managing anxiety. ^{1 2 3 4 5}

Is escitalopram generally safe for humans?

Escitalopram is generally considered safe for humans, with a low rate of people stopping treatment due to side effects. Common side effects include nausea, insomnia, and dry mouth, but these are usually mild. ^{1 2 6 7 8}

How does the drug escitalopram differ from other treatments for anxiety?

Escitalopram is unique because it is the most selective SSRI (selective serotonin reuptake inhibitor) available, which means it specifically targets serotonin levels in the brain to help reduce anxiety. It is effective for a broad range of anxiety disorders and is well-tolerated, offering advantages over other treatments like benzodiazepines, which can have more side effects. ^{1 4 9 10 11}

Research Team

Jeffrey R Strawn, MD, FAACAP

Principal Investigator

University of Cincinnati

Laura B Ramsey, PhD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

This trial is for youths aged 12-17 with generalized, social, or separation anxiety disorder. They must have a certain severity of anxiety, no recent psychotherapy initiation, and be English-speaking. Participants need normal physical exams and EKGs, not be pregnant or drug-positive, and use reliable contraception if sexually active.

Inclusion Criteria

I am between 12 and 17 years old.

Your overall level of symptoms is rated as moderate to severe by the doctor during two visits.

Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product

Exclusion Criteria

You have a mood disorder like depression, eating disorder, bipolar disorder, or psychotic disorder, except for specific types of depression and anxiety disorders.

A positive urine drug screen

You have experienced allergies, intolerance, non-response, or extreme sensitivity to escitalopram.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard or pharmacogenetically-guided escitalopram dosing for 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Escitalopram

Trial Overview The study tests escitalopram dosing in anxious youth over 12 weeks. It's double-blind with participants randomly assigned to standard dosing or doses guided by their genetics. The randomization considers sex and how well their body processes drugs.

Participant Groups

Group I: Standard dosing Experimental Treatment 1 Intervention

Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.

Group II: Pharmacogenetically-guided escitalopram dosing Experimental Treatment 1 Intervention

Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.

Escitalopram is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder

Approved in European Union as Cipralex for:

• Major depressive episodes
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder with or without agoraphobia
• Obsessive-compulsive disorder

Approved in Canada as Cipralex for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a study of 366 outpatients with panic disorder, escitalopram significantly reduced the frequency of panic attacks compared to placebo, demonstrating its efficacy in treating this condition.

Escitalopram was found to be safe and well tolerated, with a low rate of discontinuation due to adverse events, similar to that of the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram in the treatment of panic disorder: a randomized, double-blind, placebo-controlled trial. Stahl, SM., Gergel, I., Li, D.[2022]

Escitalopram, a more active isomer of citalopram, showed a faster onset of action and greater overall effectiveness in treating major depressive disorder compared to citalopram, with significant improvements in depression and anxiety symptoms observed as early as one week into treatment.

Both escitalopram and citalopram were effective in reducing symptoms of depression and anxiety compared to placebo, but escitalopram demonstrated statistically significant advantages over citalopram at multiple time points during the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. Gorman, JM., Korotzer, A., Su, G.[2019]

Escitalopram is an effective and well-tolerated treatment for various anxiety disorders and OCD, showing at least equal efficacy to paroxetine and a quicker response in panic disorder.

It has a favorable safety profile with fewer discontinuation symptoms compared to paroxetine, and its pharmacokinetics allow for convenient once-daily dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of anxiety disorders. Dhillon, S., Scott, LJ., Plosker, GL.[2019]

Escitalopram is effective and well tolerated for both short- and long-term treatment of generalized anxiety disorder, based on evidence from randomized placebo-controlled and comparator-controlled trials.

Compared to benzodiazepines and the SSRI paroxetine, escitalopram offers advantages in treating generalized anxiety disorder, making it a preferred option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram in the treatment of generalized anxiety disorder. Baldwin, DS., Nair, RV.[2013]

In a study of nine patients with generalized social anxiety disorder, citalopram was found to be generally well-tolerated and led to significant improvements in all measured outcomes.

Seven out of nine patients achieved responder status, indicating that citalopram may be a safe and effective treatment option for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citalopram for social phobia: a clinical case series. Simon, NM., Sharma, SG., Worthington, JJ., et al.[2019]

A study evaluated the adherence to prescribing guidelines for citalopram and found that implementing an EMIS safety prompt and providing prescriber training led to a significant reduction in incorrect prescriptions for patients over 65, from 8 to 1.

The interventions also decreased dangerous drug interactions involving citalopram from 44 to 8 and overall unsafe prescribing from 47 to 9, highlighting improved patient safety and resource use that could be applied to other medications with safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer citalopram use in primary care: Can staff education and prescribing prompts improve adherence to national guidance? A closed loop clinical audit, service evaluation and quality improvement study. Waller, M.[2023]

Escitalopram oxalate is an effective antidepressant that has shown robust efficacy in treating major depressive disorder and anxiety disorders, with significant improvements observed compared to placebo in multiple clinical trials.

The medication has a favorable safety profile, with a low rate of discontinuation due to adverse events, and the most common side effects, such as nausea and insomnia, were generally mild, affecting less than 10% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram. Burke, WJ.[2022]

Escitalopram, the active s-enantiomer of citalopram, is an effective selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder.

As an SSRI, escitalopram works by increasing serotonin levels in the brain, which can help improve mood and alleviate symptoms of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram (Lexapro) for depression. Masilamani, S., Ruppelt, SC.[2022]

Escitalopram is an effective first-line treatment for anxiety disorders such as panic disorder, generalized anxiety disorder (GAD), social anxiety disorder, and obsessive-compulsive disorder (OCD), showing significant efficacy compared to placebo in multiple studies involving various patient populations.

The drug is well-tolerated, with low withdrawal rates due to adverse events (7% for escitalopram vs. 8% for placebo), and it demonstrates a reduced risk of relapse in long-term studies, making it a reliable option for ongoing management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and tolerability of escitalopram in anxiety disorders: a review]. Pelissolo, A.[2022]

In a prospective open-label trial involving 10 patients with generalized social anxiety disorder, citalopram was found to be well tolerated and led to significant improvements in all outcome measures.

The study suggests that citalopram may be a safe and effective treatment option for patients who have not responded to or tolerated previous treatments for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citalopram for social anxiety disorder: an open-label pilot study in refractory and nonrefractory patients. Simon, NM., Korbly, NB., Worthington, JJ., et al.[2019]

Selective serotonin reuptake inhibitors (SSRIs), particularly escitalopram, are effective in treating anxiety symptoms associated with depression, showing significant improvement compared to placebo as early as the first week of treatment.

Escitalopram not only demonstrates rapid efficacy but also has a favorable tolerability profile, making it a preferred choice over traditional anxiolytics like benzodiazepines, which have more adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of escitalopram on anxiety symptoms in depression]. Spadone, C.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Escitalopram in the treatment of panic disorder: a randomized, double-blind, placebo-controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of anxiety disorders. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Escitalopram in the treatment of generalized anxiety disorder. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Citalopram for social phobia: a clinical case series. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Safer citalopram use in primary care: Can staff education and prescribing prompts improve adherence to national guidance? A closed loop clinical audit, service evaluation and quality improvement study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Escitalopram. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Escitalopram (Lexapro) for depression. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Efficacy and tolerability of escitalopram in anxiety disorders: a review]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Citalopram for social anxiety disorder: an open-label pilot study in refractory and nonrefractory patients. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Effects of escitalopram on anxiety symptoms in depression]. [2022]